A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma

NCT ID: NCT07348575

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2028-07-01

Brief Summary

This trial was a prospective, multicenter, randomized, controlled Phase III clinical design to compare the efficacy and safety of decitabine combined with R-CHOP (R-CHOP-D) versus R-CHOP in the treatment of primary EBV+ diffuse large B-cell lymphoma (DLBCL).

Sixty patients were randomized 1:1 into R-CHOP-D (trial group) or R-CHOP (control group). The trial consisted of a screening period (days -28 to -1), a treatment period, and a follow-up period (2 years after the end of the last trial).

Conditions

Lymphoma, Large-Cell, Diffuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decitabine in combination with R-CHOP

Decitabine in combination with R-CHOP

Group Type: EXPERIMENTAL

Decitabine in combination with R-CHOP

Intervention Type: DRUG

Decitabine in combination with R-CHOP

R-CHOP

R-CHOP

Group Type: ACTIVE_COMPARATOR

R-CHOP

Intervention Type: DRUG

Decitabine in combination with R-CHOP

Interventions

R-CHOP

Decitabine in combination with R-CHOP

Intervention Type: DRUG

Decitabine in combination with R-CHOP

Decitabine in combination with R-CHOP

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Initial treatment of diffuse large B-cell lymphoma (DLBCL) confirmed by tumor histopathology with at least one lesion on either axis More than 1.5 cm, sufficient specimens for second-generation sequencing or single-cell sequencing;

2. Age > 18 years old, < 80 years old, gender unlimited;

3. EBER+ or peripheral blood EBV-DNA of pathological specimen was greater than 103copy/ml;

4. Patients judged by the investigator to have a life expectancy of at least 6 months;

5. The patient or his legal representative must provide written informed consent prior to any research special examination or procedure.

6. Signed written informed consent before screening.

Exclusion Criteria

1. Have previously received systemic or local treatment including chemotherapy;

2. Previously received autologous stem cell transplantation;

3. Previous history of other malignant tumors, except skin basal cell carcinoma and cervical carcinoma in situ;

4. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases and serious infectious diseases;

5. Lymphoma involves the central nervous system;

6. Primary mediastinal large B-cell lymphoma;

7. Left ventricular ejection fraction < 50%;

8. Laboratory test values at the time of screening: (unless due to lymphoma);

1. Neutrophils < 1.5 x 109/L;

2. Platelet < 75 x 109/L;

3. ALT or AST were 2 times higher than the upper limit of normal, AKP and bilirubin were 1.5 times higher than the upper limit of normal;

4. creatinine levels higher than 1.5 times the upper limit of normal;

9. Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;

10. Pregnant or lactating women;

12. Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Countries

China

Other Identifiers

BR/AF/SG-05/1.1

Identifier Type: -

Identifier Source: org_study_id